Medicenna Therapeutics Corp.

Hello, and welcome to Medicina Therapeutics Fiscal First Quarter Earnings Call. All participants are in a listen-only mode. There will be a question and answer session at the end of the presentation. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Dan Ferry of LifeSci Advisors. Please go ahead.

Thank you, Operator, and thank you all for participating in today's conference call. This morning, Medisena issued a press release providing financial results and corporate updates for the quarter ended June 30th, 2021. If you have not yet seen the press release, it is available on the investor's page of Medisena's website. Before we begin, I would like to remind you that certain statements and information shared during this call constitute forward-looking information within the meaning of applicable securities laws and relate to the future operations of the company and other statements that are not historical facts, including statements related to the clinical potential and development of the MDNA 11, MDNA 55, and BISCUITS programs, the potential of the SuperKind platform, partnering activities, cash runway, and the presentation of additional data. All statements other than statements of historical fact included in this conference call, including the future plans and objectives of the company, are forward-looking statements that are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the company's expectations include the risks detailed in the recently filed annual information form, management's discussion and analysis in Form 40F, of the company and in other filings made by the company with the applicable securities regulators from time to time in Canada and the United States. Listeners are cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the company. Your caution not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this conference call are expressly qualified by this cautionary statement. Except as required by law, we do not intend and do not assume any obligation to update or revise publicly Any of the included forward-looking statements only is expressly required by Canadian and United States securities law. Now, I will turn the call over to Dr. Fahar Merchant, President and Chief Executive Officer of Medicina Therapeutics. Fahar?

Thanks, Dan, and thanks to all listening for joining us on the call today to discuss our fiscal Q1 2022 corporate update. In addition to that, I'm joined by Dr. Man Musin, our chief medical officer and Liz Williams, our chief financial officer. The last several months have been an important period of execution during which we achieved key clinical, scientific and corporate milestones. These milestones have left us poised for sustained success with a steady cadence of catalysts expected over the coming months. On today's call, We will briefly review some of these recent accomplishments, discuss our plans and expectations for the upcoming Phase I-II Ability Study of our selective, long-acting IL-2 super agonist, MDNA-11, and lay out the clinical, scientific, and corporate objectives we will be working towards as we continue through the remainder of fiscal year 2022 and beyond. So let's start with some recent accomplishments beginning with our MDNA 11 program. Last quarter, we completed the submission of our clinical trial application to a human research ethics committee in Australia in order to commence our phase one to ability study. Man is going to speak at length about the clinical trial in a few moments. But what I would like to emphasize now is that we remain on track to start enrollment in the study in Australia during calendar Q3, and we will be expanding additional sites in the US, Canada, and UK thereafter. We expect the remaining regulatory submissions and approvals for these different jurisdictions to be complete before the end of the calendar year. I will now turn your attention briefly to MDNA 55 our IL-4 guided toxin targeting recurrent glioblastoma or RGVM, the most common and uniformly fatal form of brain cancer. We were very pleased to have data from our Phase IIb trial published in the prestigious peer-reviewed journal Clinical Cancer Research last quarter, which provided important external validation for our program. These data were discussed at length during our last earnings call in May, so in the interest of time, I will now just emphasize the paper's main finding, which was that the early determination of progression-free survival using modified Raynaud criteria appears to be a strong surrogate for overall survival in recurrent GBMs. Together with previously presented modified rano-based response rates and overall survival data from the study, we believe this finding bodes well for the conduct of the planned Phase III MDA55 trial, where mRNA-based PFS could potentially be a reliable early surrogate for overall survival. Looking forward to our MDA55 program, We remain in active discussions in pursuit of a partnership to facilitate its further development and commercialization. While the details of these conversations need to remain confidential at this point, we look forward to providing a more thorough update on these activities when appropriate. In the interim, we at Medicina continue to advance the required regulatory activities associated with MDNA 55 GMP manufacturing, and future commercial supply for potential market launch. Submission of the phase three protocol to the regulators and selection of a contract manufacturing organization for long-term commercial supply of M-linear 55 will be finalized jointly with our future development partner with the expectation that the phase three registration trial can be initiated in 2022. On the discovery and preclinical front, We recently announced a peer-reviewed publication in Frontiers in Immunology, featuring data on MDNA-109, which is our IL-2 supoquin platform, which is the precursor of MDNA-11. The paper, which was independently authored by researchers at the University of Helsinki and other institutions, evaluated oncolytic adenoviruses that were either unarmed armed to code for MDNA109 or armed with wild type IL-2 in a hamster pancreatic cancer model. To provide some brief background, oncolytic adenoviruses lead to selective infection and lysis of cancer cells and can effectively deliver therapeutic levels of cytokines into tumor lesions and also promote anti-tumor immune response. Data presented in the paper showed that compared to treatment with IL-2 armed virus, treatment with MDNA109 armed virus led to superior tumor growth inhibition with a clear tendency towards achieving complete tumor regression. Mechanistic analysis showed that this was due to MDNA109's superior ability to reprogram the tumor microenvironment as mDNA109 virus induced efficient T-cell receptor signaling. It activated cytotoxic anti-cancer immune cells and inhibited tumor-protecting myeloid cells in the tumor microenvironment. Additionally, mDNA109 virus demonstrated the ability to induce a potent anti-tumor immune memory response to protect previously treated hamsters against re-challenge with pancreatic cancer cells. Collectively, these results externally validate the versatility of the mDNA109 platform and its potential to overcome limitations associated with less active versions of IL-2, such as native IL-2, particularly in immunologically cold tumors, such as pancreatic cancer, where a great unmet need exists today. Going forward, we plan to continue leveraging the versatility offered by our SuperKind platform in our discovery and preclinical programs as we seek to develop next-generation SuperKind-based therapies such as our BISCUITS platform. In addition to forming the basis of MDNA11, Our IL-2 superkine platform, MDNA 109, is also a core component of our BISCUITS program. As a reminder, BISCUITS are highly versatile and targeted by functional molecules that comprise of a superkine fused to a second anti-cancer therapeutic agent, such as a checkpoint inhibitor or a second superkine. The BISCUITS platform enables us to design bespoke immunotherapeutic agents that incorporate two synergistic mechanisms required to treat more aggressive and recalcitrant tumors, where a simultaneous two-pronged approach may be necessary to improve safety and efficacy. During the fiscal first quarter, we presented at the AACR annual meeting data on our MDNA 19, MDNA 413 biscuit. These data, which were discussed in detail during our last earnings call in May, demonstrated MDNA 19, MDNA 413's potent immune-modulating effects and its potential to overcome immunotherapy resistance mechanisms and treat immunologically cold tumors. They also showed how the BISCUITS platform can efficiently combine the enhanced immune signaling properties of multiple super kinds. In this case, an IL-2 super agonist and an IL-4, IL-13 super antagonist into a single bi-functional long acting therapeutic. Looking forward, we remain very excited about the potential of the BISCUITS platform and expect to declare a Lid Biscuit candidate, by the end of the calendar year. Lastly, before I hand the call off, I'd like to highlight two corporate milestones we achieved last quarter. These were the appointments of Drs. Mann Moussin and Kevin Mulder as CMO and CSO, respectively. You were introduced to Mann and Kevin on our last earnings call, and since then, each has continued to integrate seamlessly, into our management team. I look forward to our continued work together, and I'm thrilled that we were able to attract candidates of their caliber to the company. And with that, I'll hand the call off to Man to provide some more details on our MDNA 11 program. Man, please go ahead.